Reference Number: JO-2107-471658
Quality Systems Associate
Job Type: Permanent
We are looking for a Quality System Associate on behalf of our client based in Hertfordshire
The ideal candidate would have experience in:
- Change Controls
- Qualification and Validation documentation
- Knowledge of control of Regulatory Information
Details of responsibilities:
- To support the Product Quality Review process for company.
- To support the process of generation of Quality Agreements.
- To support the process for approving suppliers and the maintenance of the Approved Suppliers List.
- To support the maintenance of a list of Parallel Importers/Distributors of Eisai products as compiled from notifications and samples received by CompnayRegulatory Affairs.
- To support the generation of the Quality Management Systems Indicator reports.
- To support the ongoing operation, maintenance, and implementation of improvements to TrackWise processes and systems to meet companyneeds.
- To supportTraining Management System.
- To maintain copies of Corporate Policies, Guideline, Standards and Procedures.
- To write and review all SOPs associated with the Electronic TrackWise QMS
- To support the company SOP System.
- To support the internal and external audit process and audit schedules
- To participate in Audits
- To support Quality Systems training ofstaff, as required.
- To coordinate and support GMP Training
- To support the Deviations System
- To support theRisk Management System
- To provide day to day support to other members of the Quality Systems team, as appropriate.
- Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
- To perform any appropriate duties at the request of the Quality Systems Manager.